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If I make changes to my 510(k) cleared device….do I have to let the FDA know?

 

 
   

 

   

It depends on the change.  Some changes are simple enough and only require an internal “Letter to File”, whereas others are more complicated and require that you submit the change to the FDA. 

The FDA has a guidance document to help you determine the magnitude of your change:

Deciding When to Submit a 510(k) for a Change to an Existing Device

 

   
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